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作 者:张桂杰 陈明霞 宋晓莉 刘晔 康东周[1] 连增林 ZHANG Gui-jie;CHEN Ming-xia;SONG Xiao-li;LIU Ye;KANG Dong-zhou;LIAN Zeng-lin(College of Pharmacy, Yanbian University, Yanji 133000, China;Beijing Handian Pharmaceutical Co., LTD.,Handian Group, Beijing 102600, China;Beijing Red Sun Pharmaceutical Co., Ltd., Handian Group, Beijing 100103, China;Institute of Biological Chinese Medicine, Beijing Yichunag Industry Research Institute of Biological Technology, Beijing 100176, China)
机构地区:[1]延边大学药学院,吉林延吉133000 [2]汉典集团北京汉典制药有限公司,北京102600 [3]汉典集团北京红太阳药业有限公司,北京100103 [4]北京亦创生物技术产业研究院生物中药研究所,北京100176
出 处:《中国中医药信息杂志》2018年第1期79-83,共5页Chinese Journal of Information on Traditional Chinese Medicine
基 金:北京市科技计划"十病十药"中药专项(Z121102001112007)
摘 要:目的优选糖网明目颗粒喷雾制粒最佳工艺,以提高成品率及成品质量。方法分别采用单因素试验和正交试验对浸膏相对密度、辅料种类、浸膏与辅料比例、进风温度-物料温度、喷雾速率、雾化压力进行优选,确定最佳制备工艺,并进行3批样品验证,对颗粒流动性、吸湿性等制剂相关内容进行研究。结果糖网明目颗粒的最佳喷雾制粒工艺为:浸膏相对密度(60℃测定)1.15~1.20,优选辅料为糊精,干浸膏与辅料比例为58∶42,进风温度-物料温度为90-75℃,雾化压力0.12 m Pa,喷雾速率10 Hz。结论本试验优选的工艺制得颗粒成型率高、流动性和吸湿性良好,可用于糖网明目颗粒的制备。Objective To select the optimum process of granule spray for Tangwang Mingmu Granules,To improve the yield and finished product quality.Methods The effects of the relative density,the type of excipients,the ratio of the extract and the excipient,the inlet temperature-the material temperature,the spray rate and the atomization pressure were selected by single factor and orthogonal test respectively to determine the optimum preparation process.Validation for three batch sample,particle flow,hygroscopicity and other related content of the preparation were studied.Results The optimum spray granulation process of Tangwang Mingmu Granules:the relative density of extract(60℃determination)was1.15–1.20;the excipient was selected as dextrin;the ratio of dry extract and excipient was58:42;inlet temperature-material temperature was90-75℃;atomization pressure was0.12mPa;spray rate was10Hz.Conclusion The preparation technology of Tangwang Mingmu Granules optimized in this study is with high preparation rate,good fluidity and hygroscopicity,which can be used for the preparation of Tangwang Mingmu Granules.
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